Introduction to Advertising and Promotion for Medical Products

September 30, 2025 | Virtual Course

Last Year’s Agenda

Agenda Subject to Change
All Times Listed in Eastern Time

Wednesday, October 16, 2024

11:00–11:10 AM      
Welcome and Course Overview
Lauren-Caroline Tadros Potter, Assistant Director, Educational Programs, FDLI
Dominick Paul DiSabatino, Attorney, Sheppard Mullin Richter and Hampton LLP, Curriculum Advisor

11:10 AM–12:00 PM 
FDA Regulatory Authority
David L. Rosen, Partner, Foley & Lardner LLP

  • FDA Promotional Oversight Authority through the Federal Food, Drug, and Cosmetic Act
  • Defining FDA Branches and Divisions Regulating Product Promotion and Types of Advertising
  • FDA Guidances Concerning Advertising and Promotion
  • FDA Outreach Programs

12:00–12:10 PM
Break

12:10–1:00 PM
Core Fundamentals
Dominick Paul DiSabatino, Attorney, Sheppard Mullin Richter & Hampton LLP, FDLI Curriculum Advisor

  • Key Definitions for Legal, Regulatory, and Marketing Professionals
  • Claim Types and the Five Elements of Drug Promotion
  • Intent and Why It Matters
  • Preparing Submissions

1:00–2:00 PM
Lunch Break

2:00–3:00 PM
Beyond FDA
August Horvath, Partner, Foley Hoag LLP

  • Understanding the Role of Other Agencies and Non-Governmental Organizations
    • DOJ
    • FTC
    • SEC
    • HHS OIG
    • National Advertising Division
    • Better Business Bureau
  • Fundamental Laws and Guidance Documents in Connection with Other Agencies and Non-Governmental Organizations
    • Lanham Act
    • False Claims Act
    • Anti-Kickback Statute
    • Qui Tam Actions
    • SEC Anti-Fraud Provisions
  • Enforcement

3:00–3:10 PM
Break

3:10–4:00 PM     
Multi-Channel, Pre-Approval, and Non-Promotional Communication
Gillian M. Russell, Counsel, King & Spalding LLP

  • Types of Communication
  • Defining and Distinguishing Promotional Content from Scientific Exchange
  • Accepted Pre-approval Promotion—Coming Soon, Institutional
  • Help-Seeking Advertisements—Disease Awareness
  • First Amendment
  • Digital Advertising and New Technologies
  • Social Media Advertising
  • Data Privacy

4:00–4:10 PM
Break

4:10–5:00 PM     
Case Study and Practical Implementation
Katherine Armstrong, Deputy Director, National Advertising Division, BBB National Programs

You will have the opportunity to practically apply learnings from this course to a hypothetical case study reviewing promotional materials.

5:00 PM
Adjournment